Gil, H37, and H50 potatoes) and progeny derived from them are not likely to pose a plant pest 

risk and are no longer to be considered regulated articles under APHIS's Biotechnology 

Regulations (Title 7 of the Code of Federal Regulations (CFR), part 340). Since APHIS has 

determined that Fl 0, F37, El2, E24, J3, J55, J78, Gil, H37, and H50 potatoes are unlikely to 

pose a plant pest risk, APHIS will approve the petition for nomegulated status ofF! 0, F37, El2, 

E24, J3, J55, J78, Gil, H37, and H50 potatoes. Therefore, APHIS-approved pennits or 

acknowledged notifications that were previously required for environmental releases, interstate 

movement, or importation under these regulations will no longer be required for Fl 0, F37, El2, 

E24, J3, J55, J78, Gil, H37, and H50 potatoes and their progeny. Importation ofFIO, F37, El2, 

E24, J3, J55, J78, Gil, H37, and H50 potato seeds and other propagative material will still be 

subject to APHIS foreign quarantine notices at 7 CFR part 319. 

This Determination ofnomegulated status under 7 CFR part 340 for FlO, F37, El2, E24, J3, J55, 

J78, G II, H3 7, and H50 potatoes is based on APHIS' analyses of field and laboratory data 

submitted by JR Simplot, references provided in the petition, peer-reviewed publications, and 

other relevant information as described in the Plant Pest Risk Assessment (PPRA) for FlO, F37, 

E12, E24, J3, J55, J78, Gil, H37, and H50 potatoes. 

The Plant Pest Risk Assessment (PPRA) conducted on FlO, F37, El2, E24, J3, J55, J78, Gll, 

H37, and H50 potatoes concluded that they are unlikely to pose a plant pest risk and should no 

longer be subject to the regulations at 7 CFR part 340 for the following reasons: 

(I) No plant pest risk was identified from the transformation process, the insertion and/or 

expression of new genetic material, or from changes in metabolism in the Fl 0, F37, El2, 

E24, B, J55, J78, Gil, H37, and H50 potatoes. 

(2) Disease and pest incidence and/or damage were not observed to be significantly increased or 

atypical in the FlO, F37, El2, E24, J3, J55, J78, Gil, H37, and H50 potatoes compared to 

the nontransgenic counterpart or other comparators in field trials conducted in growing 

regions representative of where the FlO, F37, El2, E24, J3, J55, J78, Gil, H37, and H50 

potatoes are expected to be grown and in laboratory studies. Observed agronomic traits also 

did not reveal any significant differences that would indirectly indicate that the Fl 0, F37, 

El2, E24, J3, J55, J78, Gll, H37, and H50 potatoes are more susceptible to pests or diseases. 

Therefore no plant pest effects are expected on these or other agricultural products and no 

impacts are expected to APHIS pest control programs. 

(3) Based on an evaluation of the gene products, the compositional similarity of FlO, F37, El2, 

E24, J3, J55, J78, Gil, H37, and H50 potatoes to the parent varieties, and the observed 

interactions ofFlO, F37, El2, E24, J3, J55, J78, Gil, H37, and H50 potatoes with insects, 
H37, and HSO potatoes as a weed. 

(5) The FlO, F37, El2, E24, J3, J55, J78, Gil, H37, and HSO potatoes are not likely to increase 

the weed risk potential of other species with which they can interbreed in the U.S. or its 

territories. Gene flow, hybridization and/or introgression of inserted genes from the Fl 0, F3 7, 

El2, E24, J3, J55, J78, Gil, H37, and HSO potatoes to other sexually compatible relatives 

with which they can interbreed is not likely to occur. In the unlikely event of such 

introgression, these compatible relatives are not considered weedy or invasive. The new 

phenotype(s) conferred by genetic engineering are not likely to increase the weediness of 

these compatible relatives. 

(6) Significant changes to agricultural or cultivation practices (e.g. pesticide applications, tillage, 

irrigation, harvesting, etc.) from adoption of the FlO, F37, El2, E24, J3, J55, J78, Gil, H37, 

and HSO potatoes are not expected. 

(7) Horizontal gene transfer of the new genetic material inserted into the GE plant to other 

organisms is highly unlikely, and is not expected to lead directly or indirectly to disease, 

damage, injury or harm to plants, including the creation of new or more virulent pests, 

pathogens, or parasitic plants. 

APHIS also concludes in its PPRA that new varieties derived from FlO, F37, El2, E24, J3, J55, 

J78, Gil, H37, and HSO potatoes are unlikely to exhibit new properties that are substantially 

different from the ones observed for FlO, F37, El2, E24, 13, J55, J78, Gil, H37, and HSO 

potatoes, or those observed in other potatoes varieties not considered regulated articles under 7 

CFS part 340, that would pose a plant pest risk. 

Prior to this Determination of nonregulated status, APHIS completed an Environmental 

Assessment (EA) and Finding of No Significant Impact (FONSI) for this action, and concluded 

that a Determination ofnonregulated status under 7 CFR part 340 for FlO, F37, El2, E24, 13, 

J55, J78, G II, H37, and HSO potatoes and their progeny would have no significant impacts, 

individually or collectively, on the quality of the human environment and will have no effect on 

federally listed threatened and endangered species, species proposed for listing, or their 

designated or proposed critical habitats. APHIS also concludes with its Detennination of 

nonregulated status under 7 CFR part 340, based upon its PPRA, and informed by the EA and 

FONSI, that new varieties derived from FlO, F37, E12, E24, J3, J55, J78, Gil, H37, and HSO 

potatoes are unlikely to exhibit new properties that are substantially different from the ones 

observed for Fl 0, F37, El2, E24, 13, J55, J78, G II, H37, and HSO potatoes, or those observed 

for other potato vmieties not considered regulated articles under 7 CFR part 340, that would pose 

a plant pest risk. 
$;<1 Zc1A y 

Michael J. Firko, Ph.D. 

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service U.S. Department of Agriculture 

Date: